This study is designed to evaluate the safety of MVA85A in healthy volunteers in the UK who are latently infected with M.tb. A single vaccination with MVA85A, when administeredat a dose of 5 x 107pfu intradermally, is safe in both mycobacterially naïve individuals and those previously vaccinated with BCG. We will use the same vaccination regime in this study. Subjects will be defined as being latently infected if they have a positive elispot response to ESAT6 or CFP10. Subjects will be identified from TB contact clinics.

Willingness to allow the investigators to discuss the volunteer’s medical history with the volunteer’s GP

Screening Elispot positive (more than 50 spots/million PBMC) for at least any 1 of the 3 ESAT6 peptide pools or any one of the 3 CFP10 pools ; and screening Elispot positive for PPD.

Heaf test grade II-IV or positive Mantoux test.

CXR normal; or abnormal but not clinically significant CXR findings with no evidence of past/present TB infection or disease on the CXR.

For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day of vaccination

Agreement to refrain from blood donation during the course of the study

Written informed consent

Willingness to undergo an HIV

Exclusion Criteria

Any deviation from the normal range in biochemistry or haematology blood tests or in urine analysis

Heaf grade IV

Prior receipt of a recombinant MVA or Fowlpox vaccine

Use of any investigational or non-registered drug, live vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period

Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisolone, or equivalent, ε 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)

Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection and asplenia

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products

Evidence of cardiovascular disease

History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456183